The Pharma Data

JANUARY 27, 2021

Utilizing drug delivery platform technologies, BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus.

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The Pharma Data

DECEMBER 20, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumours to treat specific types of cancer.

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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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Codon

JANUARY 21, 2024

2 AP: A news story in Nature about your organization, 1Day Sooner, discussed some recent challenge trials involving the hepatitis C virus. We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. That's not coincidental.

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Agency IQ

JUNE 29, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

SEPTEMBER 29, 2023

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

OCTOBER 29, 2020

We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations.

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The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife. million seed funding round.

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The Pharma Data

MAY 15, 2021

We may also use such information to fulfill prizes, track compliance with the applicable sweepstakes or promotion rules, or for content improvement and feedback purposes. If you access the website from outside of the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”.

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The Pharma Data

APRIL 27, 2021

reflecting lower treatment compliance during the COVID-19 pandemic. On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. First-quarter Fabrazyme ® sales increased 4.7% In the U.S. sales decreased 2.9% Net sales (€ million).

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Amgen (NASDAQ:AMGN) announced that the U.S. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

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The Pharma Data

DECEMBER 14, 2020

BetterLife is refining and developing drug candidates from a broad set of complementary interferon-based technologies which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV), and/or to directly inhibit tumors to treat specific types of cancer.

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The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions.

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The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions.

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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Drug & Device Law

JULY 31, 2023

However, licensed software can be a UCC sale of “goods.” Rather, Lowe relied on broadly applicable negligence principles involving consumer expectation and compliance with industry standards, as it would for any run-of-the-mill tangible product. So far, the would-be liability expanders haven’t done very well. 1145, 1165 n.135

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